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IDx, a privately-held AI diagnostics company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo request to market IDx-DR, an AI-based diagnostic system for the autonomous detection of diabetic retinopathy, a leading cause of blindness. IDx-DR is the first autonomous, AI-based diagnostic system authorized for commercialization by the FDA.

“The FDA’s authorization to market IDx-DR is a historic moment that has the potential to launch a transformation in the way U.S. healthcare is delivered,” said Dr. Michael Abramoff, MD, PhD, founder and president of IDx. “Autonomous AI systems have massive potential to improve healthcare productivity, lower healthcare costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”